(120 days)
The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.
Veta™ Peritoneal Dialysis Catheters are side-ported silicone catheters with a single and double retention cuff, available in a range of lengths and French sizes and in either a straight or spiral tip configuration.
The provided document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-driven medical devices. This document refers to a conventional medical device (Veta™ Peritoneal Dialysis Catheter), and its clearance is based on in vitro testing and substantial equivalence to predicate devices, rather than performance metrics from clinical or AI-specific studies.
Therefore, most of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Leakage | Met requirements of BS EN 1618-1997 |
| Flow Rate | Met requirements of BS EN 1618-1997 |
| Tensile Strength | Met requirements of BS EN 1618-1997 |
| Corrosion | Met requirements of BS EN 1618-1997 |
| Biocompatibility | Met requirements of ISO 10993 or identical to legally marketed devices |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The "test set" in this context refers to physical samples of the catheter used for in vitro engineering tests, not a dataset of patient cases. The specific number of catheters tested is not provided, but it would have been sufficient to meet the standards.
- Data Provenance: Not applicable. This was in vitro testing, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for in vitro engineering tests is established by adhering to published performance standards (e.g., BS EN 1618-1997) and verified by standard laboratory test methods, not by expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of clinical findings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done (or is relevant) as this is not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance was done (or is relevant) as this is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the in vitro tests was defined by compliance with established engineering and biocompatibility standards (BS EN 1618-1997 and ISO 10993).
8. The sample size for the training set
- Not applicable. This device did not involve machine learning; therefore, there was no training set.
9. How the ground truth for the training set was established
- Not applicable. There was no training set.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.